KUALA LUMPUR (Bernama): The Health Ministry will ensure that the Covid-19 vaccine approved for registry and marketing in Malaysia is safe, of good quality and optimum efficacy
Health director-general Tan Sri Dr Noor Hisham Abdullah said that the Ministry will do this through the National Pharmaceutical Regulatory Agency (NPRA), adding that it will follow the requirements set by the World Health Organisation (WHO)
He said that based on the "WHO Target Product Profiles for Covid-19 Vaccines" published in April, the vaccine should show a minimum level point estimate vaccine efficacy (VE) of 50 per cent in clinical trials, although a point estimate of 70 per cent is preferred.
"The vaccine should generate antibodies that can stay in a person’s body for at least six months, but VE is the endpoint in the third phase of clinical trials," said Dr Noor Hisham.
He added that currently no phase three clinical studies have been published for the Covid-19 vaccine that can be evaluated by the NPRA.
"As such, the VE information for every vaccine candidate has not been confirmed, ” he wrote on his Facebook page on Saturday (Nov 28) night.
On safety, Dr Noor Hisham said the vaccine must have a sufficient safety profile so that the benefits outweigh the risks, adding that the vaccine should have only mild and transient adverse effects.
He added that the quality of the vaccine will be determined based on evidence of compliance with good manufacturing practices.
Dr Noor Hisham said that the manufacturing data should show that all material sources used to produce the vaccine are adequately controlled according to international standards.
"This includes the history and qualification of cell banks, virus banks and identification of all animal-derived materials used for cell culture and virus growth," he said.
Dr Noor Hisham also said that the manufacturing process data that must be provided includes the critical process parameters and critical quality attributes like purity, identity, and the potency of the vaccine.
He added that the manufacturing process data must also include batch records, defined hold times and the in-process testing scheme in addition to having to submit the specifications for drug substance and drug product.
"Apart from that, other data such as consistent manufacturing process, including document protocol, validation process and research reports are also required. Even the stability data supporting the vaccine expiration and optimum temperature is also important in order to ensure vaccine quality if used within the recommended temperature range, ” he said. - Bernama
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